Prosom News

PROSOM SUMMARY

PROSOM™ (estazolam tablets)CS-IV

ProSom (estazolam), a triazolobenzodiazepine derivative, is an oral hypnotic agent. Estazolam occurs as a fine, white, odorless powder that is soluble in alcohol and practically insoluble in water. The chemical name for estazolam is 8-chloro-6-phenyl-4H-s-triazolo[4,3-(alpha)] [1,4]benzodiazepine. The empirical formula is C16H11ClN4.

Because insomnia is often transient and intermittent, the prolonged administration of ProSom is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.

There is evidence to support the ability of ProSom to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY).

No effect of itraconazole on the single oral dose pharmacokinetics and pharmacodynamics of estazolam. [2002.06]To examine the involvement of cytochrome P450 3A4 in the metabolism of estazolam, the effect of itraconazole, a potent inhibitor of this enzyme, on the single oral dose pharmacokinetics and pharmacodynamics of estazolam was studied in a double-blind randomized crossover manner... The current study showed no significant effect of itraconazole on the single oral dose pharmacokinetics and pharmacodynamics of estazolam, suggesting that cytochrome P450 3A4 is not involved in the metabolism of estazolam to a major extent.

Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons [Completed]
Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as
cognitive functions, which in turn could result in lethal incidents including falls
especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and
benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail
population. In this 8-week open-label study, we examined changes in motor and cognitive
functions following the discontinuation of BZD hypnotics in older persons.
OBJECTIVES & HYPOTHESES
1. Primary Objective The primary objective is to examine the feasibility of discontinuing
BZD-derivative hypnotics in older people.
2. Secondary Objectives
1. One of the secondary objectives is to examine the magnitude of discontinuing
BZD-derivative hypnotics in the stability of body.
2. Another secondary objective is to examine the magnitude of discontinuing
BZD-derivative hypnotics in cognitive function.
Hypotheses
1. More than 80% of the participants will complete and tolerate all the study procedures.
2a. Participants will show an improvement in the stability of body. 2b. Participants will
show an improvement in the cognitive function globally as well as specifically in attention.